Remote Brief Intervention and Referrals to Treatment Service for Alcohol

Significance: The USPHSTF, SAMHSA, CDC, and NIAAA have affirmed the importance of screening
in medical settings for alcohol consumption that exceeds the NIAAA low risk limits, brief
educational and motivational counseling for those who screen positive or have other evidence
of an Alcohol Use Disorder, and, when appropriate, referral to treatment (SBIRT). However,
translation to clinical practice continues to be elusive. Polaris Health Directions (Small
Business) and the University of Massachusetts Medical School (Research Institute) have
partnered to solve this problem by creating the Remote Brief Intervention and Referral to
Treatment service for alcohol (R-BIRT), a telehealth service for delivering evidence based
alcohol brief interventions and referral to treatment during a medical encounter in a
cost-effective, sustainable way.

Investigators: The investigators have extensive expertise in SBIRT for alcohol (Boudreaux,
Bernstein); telehealth (Boudreaux); development, testing, and marketing of behavioral
intervention technologies (Boudreaux, Harralson); comparative effectiveness trial design and
analysis (Barton); and health economics (Sachs). Combined, the team has over 100 publications
related to SBIRT and constituent technology domains.

Innovation: This Phase 2 STTR will pioneer telehealth delivery of SBIRT for alcohol. It will
be flexible enough for a variety of medical settings, and will develop and expand software
capable of facilitating both telehealth and in-person SBIRT delivery models. It will further
innovate SBIRT research and clinical practice by exploring mechanisms of action, an objective
rarely incorporated into SBIRT studies.

Approach: The design is a two arm, single blind (outcomes assessor), randomized,
non-inferiority trial. Emergency department (ED) patients (n=356) who drink above the NIAAA
low risk limits or have evidence of an Alcohol Use Disorder will be randomized to the
telehealth model (R-BIRT) or a gold-standard in-person intervention (SBIRT) and followed for
6 months post-visit using a multi-method outcomes attainment plan. The study will establish
the non-inferiority of the telehealth model compared to the in-person model in reducing
alcohol use and alcohol related consequences, while showing that the telehealth model is the
more cost effective of the two. Mechanisms of action, including patient knowledge of low risk
drinking limits, motivation, self-efficacy, substance abuse treatment initiation, and
self-help program engagement, will be examined.

Environment: With the success of the R-BIRT Phase 1 and other relevant projects, including
previous large scale Phase 2 STTR clinical trials, Polaris and UMass have clearly established
their capability of successfully carrying out this study, disseminating its results, and
marketing the final product.

Impact: Because alcohol misuse, abuse, and dependence carries an enormous burden in both
human suffering and healthcare costs, a strategy that provides high quality, evidence based
care in a manner that is more cost effective and easier than existing models has potential to
exert a substantial impact on public health.

Inclusion Criteria:

- 18 years old or older.

- Presenting for care to the UMass Emergency Department.

- Screens positive for alcohol use above the NIAAA age and gender matched low risk
drinking limits.

- AUDIT-10 score greater than 8 suggesting risk for an Alcohol Use Disorder.

Exclusion Criteria:

- Altered mental status (not alert, not oriented, psychotic, persistent intoxication).

- Patients who present as initially intoxicated but who are no longer intoxicated later
in the visit can be approached.

- Currently in alcohol treatment.

- DAST-10 score greater than 3.

- Currently in state custody or pending legal action that might lead to imprisonment.

- Cannot paraphrase the study requirements.

- No reliable telephone access.

- Does not speak English.

- Already enrolled into the trial.